Epilepsy Adherence in Children and Technology (eACT)

NCT ID: NCT03817229

Last Updated: 2025-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 268 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-15
• Study Completion Date: 2024-08-01

Brief Summary

Fifty-eight percent of children with new-onset epilepsy do not take their antiepileptic drugs (AEDs) as prescribed, which is associated with continued seizures, mortality, poor quality of life, and high healthcare costs. Evidence-based adherence interventions are lacking and critically needed, especially for children with epilepsy, who represent an underserved population in pediatrics. The current proposal is a mHealth sequential, multiple assignment, randomized trial (SMART) focused on providing education, automated digital reminders, and individualized adherence feedback, as well as teaching problem-solving skills, with the goal of improving adherence and quality of life and decreasing seizures and health care utilization.

Detailed Description

Non-adherence to antiepileptic drugs (AEDs) is a common problem (i.e., 58% of patients have some level of non-adherence) for young children with newly diagnosed epilepsy, with potentially devastating consequences. AED non-adherence is associated with a 3-fold increased risk of seizures, poor quality of life, inaccurate clinical decision-making, and higher health care utilization and costs. One of the primary barriers to adherence is forgetting, which may be particularly amenable to mHealth (mobile technology in healthcare) interventions. Despite the critical need to develop and implement interventions to improve adherence, there are few family-based interventions for young children with epilepsy and their families. One existing intervention is highly promising; however, this intervention requires six in-person sessions, which can be impossible for families who lack routine access to tertiary specialty care due to time, financial, or transportation constraints. Thus, unmet medical and psychosocial needs of the underserved pediatric epilepsy population are perpetuated and compounded by limited access to this state of the art care. The overall goal is to test a mHealth adherence intervention that is easily accessible using a stepped up care model based on individual needs. This stepped up care model will conserve patient, family, and provider time, costs and resources. The aim of this multi-site R01 is to conduct a two-stage, sequential, multiple assignment, randomized trial (SMART) to evaluate the effectiveness of mHealth intervention strategies for improving AED adherence in caregivers of young children with epilepsy. A two-month baseline period will be followed by two stages. In Stage 1 (3-months long), non-adherent caregivers (< 95%) will be randomized to a mHealth education module and automated digital reminders (control) or the mHealth education module, automated digital reminders, and individualized adherence feedback based on real-time adherence monitoring (treatment) to address the primary barrier of forgetting. At the beginning of Stage 2 (two months long), caregivers randomized to treatment who do not achieve adherence > 95% (response) by the end of Stage 1 will be re-randomized to either continued individualized adherence feedback or individualized adherence feedback augmented with two mHealth problem-solving modules (translated from the PIs existing RCTs) with a therapist. Thus, there are three intervention strategies embedded in this SMART: #1 control, #2 treatment, and #3 problem-solving augmented treatment if nonresponsive at three months. The primary outcome is electronically-monitored adherence and secondary outcomes include seizure severity/frequency, quality of life, and healthcare utilization. If the aims of the project are achieved, this study would have a large impact on pediatric epilepsy, with the potential to change clinical practice for treating non-adherence. The SMART design would allow the investigators to identify patients who are most likely to respond to interventions and step up care with more time- and resource-intensive interventions (i.e., problem-solving with a therapist via the web), when necessary.

Conditions

Epilepsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control Group

mHealth education module and automated digital reminders

Group Type: ACTIVE_COMPARATOR

Education microlearning sessions

Intervention Type: BEHAVIORAL

mHealth education microlearning sessions

Automated digital reminders

Intervention Type: BEHAVIORAL

reminders from electronic monitors based on texts or lights/chimes

Treatment Group-Individualized Feedback Only

mHealth education module, automated digital reminders, and individualized adherence feedback.

Group Type: EXPERIMENTAL

Education microlearning sessions

Intervention Type: BEHAVIORAL

mHealth education microlearning sessions

Automated digital reminders

Intervention Type: BEHAVIORAL

reminders from electronic monitors based on texts or lights/chimes

Individualized Adherence Feedback Report

Intervention Type: BEHAVIORAL

Individual Adherence Feedback reports sent to parents weekly

Treatment Group-Individualized Feedback + Problem-Solving

mHealth education module, automated digital reminders, individualized adherence feedback, and 2 problem solving sessions with a therapist.

Group Type: EXPERIMENTAL

Education microlearning sessions

Intervention Type: BEHAVIORAL

mHealth education microlearning sessions

Automated digital reminders

Intervention Type: BEHAVIORAL

reminders from electronic monitors based on texts or lights/chimes

Problem-solving mHealth module

Intervention Type: BEHAVIORAL

mhealht problem solving module with 2 telehealth sessions with a therapist

Individualized Adherence Feedback Report

Intervention Type: BEHAVIORAL

Individual Adherence Feedback reports sent to parents weekly

Interventions

Education microlearning sessions

mHealth education microlearning sessions

Intervention Type: BEHAVIORAL

Automated digital reminders

reminders from electronic monitors based on texts or lights/chimes

Intervention Type: BEHAVIORAL

Problem-solving mHealth module

mhealht problem solving module with 2 telehealth sessions with a therapist

Intervention Type: BEHAVIORAL

Individualized Adherence Feedback Report

Individual Adherence Feedback reports sent to parents weekly

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Children ages 2-12 years

2. Epilepsy diagnosis < 2 years

3. Ability to read/speak English

Exclusion Criteria

1. Major comorbid neurodevelopmental or medical disorders (e.g., Autism, diabetes)

2. Plan to wean AEDs for 18 months

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: collaborator

Children's Hospital of Orange County

OTHER

Sponsor Role: collaborator

University of Cincinnati

OTHER

Sponsor Role: collaborator

Nationwide Children's Hospital

OTHER

Sponsor Role: collaborator

North Carolina State University

OTHER

Sponsor Role: collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Avani Modi, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

Childrens Hospital of Orange County

Orange, California, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

References

Wagner JL, Patel AD, Huszti H, Schmidt M, Smith G, Bhatia S, Guilfoyle SM, Lang A, Buschhaus S, Williams S, Ardo J, Davidian M, Modi AC. The eACT study design and methods: A sequential, multiple assignment, randomized trial of A novel adherence intervention for youth with epilepsy. Contemp Clin Trials. 2024 Dec;147:107739. doi: 10.1016/j.cct.2024.107739. Epub 2024 Nov 10.

Reference Type: DERIVED

PMID: 39532238 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R01NR017794-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

FP00001781

Identifier Type: -

Identifier Source: org_study_id